MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anemia (1706)

Event Date 01/01/2017

Event Type  Injury  

Event Description

During its post-market surveillance activities on 25-may-2022, penumbra inc.Became aware of a journal article titled, "clinical outcomes of percutaneous debulking of tricuspid valve endocarditis in intravenous drug users" (aktar et al.2021).In this dual center retrospective study, twenty-five patients underwent percutaneous debulking procedures in the tricuspid valve using the indigo system aspiration catheter 8 (cat8) between january 2017 and december 2019.It was reported that post procedure blood transfusion was needed in fifty percent due to volume of blood aspirated during the cases of eleven patients.There were no procedural related complications or vascular complications other than blood loss from aspiration.The events documented in this article are associated with an off-label use of a penumbra product.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, distal embolization, hematoma or hemorrhage at access site, inability to completely remove thrombus, hemorrhage, vessel spasm, thrombosis, dissection, or perforation, peripheral thromboembolic events.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14741622
• MDR Text Key: 294596526
• Report Number: 3005168196-2022-00298
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention